Cipla’s US-arm recalls drug due to improper seal, could have ‘life threatening’ effects; shares fall

Cipla’s stock fell one percent in early trade on November 11 after the pharma player’s USA-based subsidiary recalled one lot of its medicine on seal integrity issues.

Cipla’s subsidiary InvaGen Pharmaceuticals Inc., USA, is voluntarily recalling one lot of Vigabatrin for oral solution, USP 500mg. Vigabatrin for oral solution, USP 500 mg, has been found to have issues with the seal, which would allow for powder to leak from the pouch.

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As of 9.22 am, shares of Cipla were trading at Rs 1,208.3, down by 0.89 percent on the NSE.

The product is used for the treatment of refractory complex partial seizures as adjunctive therapy in patients 2 years of age and older who have responded adequately to several alternative treatments.

Cipla noted that there is a “reasonable probability” that inaccurate dosing of the medicine could result in serious adverse effects, such as intoxication or seizures, which might be life-threatening and require immediate medical attention.

Also Read | Cipla’s arm InvaGen Pharma USA recalls anti-epileptic drug due to packaging issues

“InvaGen Pharmaceuticals is notifying the customer level through press releases, letters, telefax, telephone, email, and on-site visits, and is coordinating the return of all recalled products,” said Cipla, in a filing with the exchanges.

Earlier in November, Cipla’s European subsidiary Cipla EU completed the acquisition of an additional stake in Cipla Maroc SA, Morocco, a joint venture company. Cipla EU acquired an additional 15.1 percent of Cipla Maroc SA, Morocco shares from the The Pharmaceutical Institute (PHI) for MAD 81.1 million or around $8.05 million.

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